Diclofenac Sodium

Product NDC: 24208-457
Requested package NDC: 24208-457-05
11-digit product format: 242080457
Labeler code: 24208
Product ID: 24208-457_4965dd94-e9f5-0494-e063-6294a90ac40f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diclofenac Sodium
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Bausch & Lomb Incorporated
Application: ANDA078792
Marketing category: ANDA
Marketing start: 2007-12-28
Substance: DICLOFENAC SODIUM
Active strength: 1 mg/mL
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078792-001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2007-12-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A078792-001	AT

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2007-12-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2007-12-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2007-12-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2007-12-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2007-12-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2007-12-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2007-12-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2007-12-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2007-12-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2007-12-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2007-12-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2007-12-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2007-12-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2007-12-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2007-12-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2007-12-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2007-12-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT		2007-12-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2007-12-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2007-12-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT		2007-12-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT		2007-12-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT		2007-12-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT		2007-12-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT		2007-12-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT		2007-12-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT		2007-12-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2007-12-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2007-12-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2007-12-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2007-12-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2007-12-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2007-12-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2007-12-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2007-12-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2007-12-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2007-12-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2007-12-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2007-12-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2007-12-28	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078792-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078792-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078792-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078792-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078792-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078792-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078792-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078792-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078792-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078792-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078792-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078792-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078792-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078792-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078792-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078792-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078792-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078792-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078792-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078792-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078792-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078792-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078792-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078792-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078792-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078792-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078792-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078792-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078792-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078792-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078792-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078792-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078792-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078792-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078792-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078792-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078792-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078792-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078792-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078792-001	AT	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Diclofenac Sodium
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DICLOFENAC SODIUM	1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
QTG126297Q	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
854801	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
39dfffb0-612a-48f3-8db5-1a59899b91e9	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75	Product name	2	20250814
111d457e-3138-4512-b0ba-d0cd760c4055	Product name	3	20250225
0426261e-1bb9-b78b-abd2-80da765a7e3e	Product name	2	20240513
7b6158ae-c3f4-3d73-c35f-6f5d18b9efd7	Product name	5	20240320
0ac2f11f-f58d-baf2-71a0-680993b48a61	Product name	2	20231211
855d63c3-b090-4636-8fc7-6d39ad23c44f	Product name	1	20230829
bb58f410-04be-65dd-9211-e89ead899698	Product name	6	20230323
0fcbc38a-8b29-3348-1cef-5222ea53484f	Product name	4	20220516
c4e1eedc-aca2-4551-8382-89144ed9d049	Product name	3	20220126
8d368a34-1453-43ea-828d-0dbcd72b8794	Product name	8	20210622
d6bab9d2-edce-a213-4796-226ab15472c3	Product name	6	20200616
2487e6ef-d419-42fc-aaf8-7acc805d2370	Product name	2	20170718
e071c814-e5e7-e7ed-ec76-428765d9c66b	Product name	2	20151120
93148e06-b8d7-4e6c-853e-62f807d17fbb	Product name	1	20151014
dbb00be6-fb1c-4b0a-a770-31f7e05e247e	Product name	1	20150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
24208-457-05	Diclofenac Sodium	1 in 1 CARTON	SOLUTION/ DROPS	1	14
24208-457-05	Diclofenac Sodium	5 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	5	14
24208-457-25	Diclofenac Sodium	2.5 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	2.5	14
24208-457-25	Diclofenac Sodium	1 in 1 CARTON	SOLUTION/ DROPS	1	14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
24208-457-05	ML - Milliliter	24208-457	0756dcb4-9845-4451-b55b-7d10a9730d10	1	2012-07-24
24208-457-25	ML - Milliliter	24208-457	16a64fa3-942f-42a2-a87b-8e17b8e7ad4e	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DICLOFENAC SODIUM	ACTIVE INGREDIENT	QTG126297Q	DICLOFENAC SODIUM SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]	5
DICLOFENAC	ACTIVE MOIETY	144O8QL0L1	DICLOFENAC SODIUM SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]	5
BORIC ACID	INACTIVE INGREDIENT	R57ZHV85D4	DICLOFENAC SODIUM SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]	5
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	DICLOFENAC SODIUM SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]	5
POLYOXYL 35 CASTOR OIL	INACTIVE INGREDIENT	6D4M1DAL6O	DICLOFENAC SODIUM SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]	5
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	DICLOFENAC SODIUM SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]	5
TROMETHAMINE	INACTIVE INGREDIENT	023C2WHX2V	DICLOFENAC SODIUM SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]	5
WATER	INACTIVE INGREDIENT	059QF0KO0R	DICLOFENAC SODIUM SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]	5
DICLOFENAC SODIUM	ACTIVE INGREDIENT	QTG126297Q	DICLOFENAC SODIUM SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	2
DICLOFENAC	ACTIVE MOIETY	144O8QL0L1	DICLOFENAC SODIUM SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	2
BORIC ACID	INACTIVE INGREDIENT	R57ZHV85D4	DICLOFENAC SODIUM SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	DICLOFENAC SODIUM SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	2
POLYOXYL 35 CASTOR OIL	INACTIVE INGREDIENT	6D4M1DAL6O	DICLOFENAC SODIUM SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	2
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	DICLOFENAC SODIUM SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	2
TROMETHAMINE	INACTIVE INGREDIENT	023C2WHX2V	DICLOFENAC SODIUM SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	DICLOFENAC SODIUM SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	2
DICLOFENAC SODIUM	ACTIVE INGREDIENT	QTG126297Q	DICLOFENAC SODIUM SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]	1
DICLOFENAC SODIUM	ACTIVE INGREDIENT	QTG126297Q	DICLOFENAC SODIUM SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.]	1
DICLOFENAC	ACTIVE MOIETY	144O8QL0L1	DICLOFENAC SODIUM SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]	1
DICLOFENAC	ACTIVE MOIETY	144O8QL0L1	DICLOFENAC SODIUM SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.]	1
BORIC ACID	INACTIVE INGREDIENT	R57ZHV85D4	DICLOFENAC SODIUM SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.]	1
BORIC ACID	INACTIVE INGREDIENT	R57ZHV85D4	DICLOFENAC SODIUM SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	DICLOFENAC SODIUM SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	DICLOFENAC SODIUM SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]	1
POLYOXYL 35 CASTOR OIL	INACTIVE INGREDIENT	6D4M1DAL6O	DICLOFENAC SODIUM SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.]	1
POLYOXYL 35 CASTOR OIL	INACTIVE INGREDIENT	6D4M1DAL6O	DICLOFENAC SODIUM SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]	1
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	DICLOFENAC SODIUM SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.]	1
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	DICLOFENAC SODIUM SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]	1
TROMETHAMINE	INACTIVE INGREDIENT	023C2WHX2V	DICLOFENAC SODIUM SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.]	1
TROMETHAMINE	INACTIVE INGREDIENT	023C2WHX2V	DICLOFENAC SODIUM SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	DICLOFENAC SODIUM SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	DICLOFENAC SODIUM SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
24208-457	DICLOFENAC SODIUM SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]	12	Current NDC, Legacy NDC, 4 package rows	20240726_39dfffb0-612a-48f3-8db5-1a59899b91e9.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac Sodium	DICLOFENAC SODIUM	Bausch & Lomb Incorporated	39dfffb0-612a-48f3-8db5-1a59899b91e9	2026-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078792 application number: ANDA078792 ndc (package): 24208-457-05 ndc (product): 24208-457 ndc11 (package): 24208045705
Diclofenac Sodium	DICLOFENAC SODIUM	A-S Medication Solutions	5d74488c-e092-415d-b19b-05318380d9b1	2024-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078792 application number: ANDA078792

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
QTG126297Q	DICLOFENAC SODIUM	15307-79-6	DICLOFENAC SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
854801	diclofenac sodium 0.1 % Ophthalmic Solution	PSN	5d74488c-e092-415d-b19b-05318380d9b1	15
854801	diclofenac sodium 1 MG/ML Ophthalmic Solution	SCD	5d74488c-e092-415d-b19b-05318380d9b1	15
854801	diclofenac sodium 0.1 % Ophthalmic Solution	SY	5d74488c-e092-415d-b19b-05318380d9b1	15
854801	diclofenac sodium 0.1 % Ophthalmic Solution	PSN	39dfffb0-612a-48f3-8db5-1a59899b91e9	14
854801	diclofenac sodium 1 MG/ML Ophthalmic Solution	SCD	39dfffb0-612a-48f3-8db5-1a59899b91e9	14
854801	diclofenac sodium 0.1 % Ophthalmic Solution	SY	39dfffb0-612a-48f3-8db5-1a59899b91e9	14
854801	diclofenac sodium 0.1 % Ophthalmic Solution	PSN	6bec35d6-500d-4570-b2ff-ce7b4fc801df	2
854801	diclofenac sodium 1 MG/ML Ophthalmic Solution	SCD	6bec35d6-500d-4570-b2ff-ce7b4fc801df	2
854801	diclofenac sodium 0.1 % Ophthalmic Solution	SY	6bec35d6-500d-4570-b2ff-ce7b4fc801df	2
854801	diclofenac sodium 0.1 % Ophthalmic Solution	PSN	41c80e79-36fd-4b90-bae1-55d6042c3ca2	1
854801	diclofenac sodium 0.1 % Ophthalmic Solution	PSN	888d7749-bdbc-4788-a215-9c0447aee79a	1
854801	diclofenac sodium 1 MG/ML Ophthalmic Solution	SCD	41c80e79-36fd-4b90-bae1-55d6042c3ca2	1
854801	diclofenac sodium 1 MG/ML Ophthalmic Solution	SCD	888d7749-bdbc-4788-a215-9c0447aee79a	1
854801	diclofenac sodium 0.1 % Ophthalmic Solution	SY	41c80e79-36fd-4b90-bae1-55d6042c3ca2	1
854801	diclofenac sodium 0.1 % Ophthalmic Solution	SY	888d7749-bdbc-4788-a215-9c0447aee79a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
24208-457-05	24208045705	1 BOTTLE, DROPPER in 1 CARTON (24208-457-05) / 5 mL in 1 BOTTLE, DROPPER	2007-12-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diclofenac Sodium Ophthalmic Solution, 0.1% (Sterile) Rx only	Bausch & Lomb Incorporated	2026-01-27	HUMAN PRESCRIPTION DRUG LABEL	14
Diclofenac Sodium Ophthalmic Solution, 0.1% (Sterile) Rx only	RPK Pharmaceuticals, Inc.	2024-12-19	HUMAN PRESCRIPTION DRUG LABEL	2
Diclofenac Sodium Ophthalmic Solution, 0.1% (Sterile) Rx only	A-S Medication Solutions	2024-06-10	HUMAN PRESCRIPTION DRUG LABEL	15
Diclofenac Sodium Ophthalmic Solution, 0.1% (Sterile)	H.J. Harkins Company, Inc. \| Bausch & Lomb Incorporated \| Esteve Quimca S.A.	2011-10-27	HUMAN PRESCRIPTION DRUG LABEL	1
Diclofenac Sodium Ophthalmic Solution, 0.1% (Sterile)	Physicians Total Care, Inc.	2011-01-31	HUMAN PRESCRIPTION DRUG LABEL	2
Diclofenac Sodium Ophthalmic Solution, 0.1% (Sterile)	Rebel Distributors Corp	2010-09-24	HUMAN PRESCRIPTION DRUG LABEL	1